Mandibular Stability and Dentofacial Deformity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexandre Meireles Borba, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01486069
First received: December 2, 2011
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

The present study intends to clarify whether there is positional mandibular stability in patients to be submitted to orthognathic surgery. In case of any instability exists, it is needed to understand if this could be related to a particular type of dentofacial deformity or could have any short-term or long-term influence on outcomes of the orthognathic surgery.


Condition
Maxillofacial Abnormalities

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Perioperative Mandibular Positional Stability in Subjects With Dentofacial Deformity

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Variability in mandibular position for different dental occlusion registrations [ Time Frame: Perioperative to orthognathic surgery ] [ Designated as safety issue: Yes ]
    Centric occlusion, maximum intercuspation and occlusion under general anesthesia


Enrollment: 30
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dentofacial Deformity
Patients with dentofacial deformities candidate to orthognathic surgery

Detailed Description:

Treatment of skeletal discrepancy nowadays is mainly performed by combination of clinical and surgical procedures in which orthodontics intends to align the teeth according to their respective alveolar bone and the surgical procedure - orthognathic surgery - realign the jaws in an adequate position among themselves and related to the rest of the craniofacial skeleton. Orthognathic surgery has developed throughout the years technically as well as regarding fixation devices for the operated segments, providing prediction of results with a low complication incidence. A debate point is related to the possible instability of the mandibular position as a reference for surgical planning due to its articulation with the temporal fossa, the temporomandibular joint. However, studies have shown that not always the mandible position obtained for the articulator reflects the position observed in subjects after induction of general anesthesia. Since there is no evidence that indicates that any alteration of the position of the mandible could influence the outcomes of a orthognathic surgery nor any relationship of a certain type of dentofacial deformity that would be beneficiated by an specific order of surgery or skeletal reference (maxilla or mandible), the present study intends to clarify some of these questions.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Data will be obtained from subjects to be submitted to orthognathic surgery by the Department of Oral & Maxillofacial Surgery of the Hospital Geral Universitário of the city of Cuiabá - Brazil during the period of March 2012 through March 2013. Considering the local demand, thirty subjects are expected to be included in the research.

Criteria

Inclusion Criteria:

  • Dentofacial Deformity candidate to orthognathic surgery;
  • Systemically capable to be submitted to the orthognathic surgery.

Exclusion Criteria:

  • Patient's health condition is not stable enough to guarantee uneventful outcome;
  • Required data unable to be achieved;
  • Patient not agreeing to participate to the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01486069

Locations
Brazil
Hospital Geral Universitario
Cuiaba, Mato Grosso, Brazil, 78000-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Alexandre M Borba, DDS, MSc University of Sao Paulo
  More Information

Publications:
Responsible Party: Alexandre Meireles Borba, Principal Investigator - PhD Student in Oral and Maxillofacial Surgery, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01486069     History of Changes
Other Study ID Numbers: FOUSP - PhD Surg - 01
Study First Received: December 2, 2011
Last Updated: June 12, 2013
Health Authority: Brazil: Ethics Committee (Plataforma Brasil- Ministério da Saúde)

Keywords provided by University of Sao Paulo:
Dentofacial Deformity
Orthognathic Surgery
Mandible
Orthognathic Surgical Procedures

Additional relevant MeSH terms:
Dentofacial Deformities
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 22, 2014